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Drug Safety Update - February 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2022 (PDF).

This issue notes that a UK COVID-19 Antivirals Pregnancy Registry has been created. The safety of COVID-19 antivirals in pregnancy has not been established and information is therefore requested for any pregnancies which occur during use of an antiviral, including paternal use. Reports are welcomes from healthcare professionals, pregnant women and partners of pregnant women.

This issue also highlights an observed increased risk of cardiovascular events in patients with rheumatoid arthritis following co-administration of azithromycin with hydroxychloroquine. Based on this data, healthcare professionals are advised to carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. Clinicians are also reminded to be vigilant for psychiatric reactions associated with hydroxychloroquine or chloroquine, especially in the first month of treatment.

This issue contains the latest COVID-19 vaccine and medicine information including the recent approval of the Nuvaxovid® COVID-19 vaccine developed by Novavax. The update also advises that weekly summaries of Yellow Card reporting events associated with coronavirus vaccine continues to be published.

Lastly in this issue is a summary of letters to healthcare professionals in January. These generally related to supply issues and recalls as well as details of the consultation proposal to make estradiol 10 microgram vaginal tablets available from pharmacies.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.